Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-36 are pending.
Claims 19-22 and 26-36 are withdrawn from examination being part of the nonelected groups.
Claims 1-18 and 23-25 are being examined.
All previous objections and rejections not set forth below have been withdrawn in view
of applicant’s amendments to the claims. However, the claim amendments by the Applicant necessitated new prior art references and new grounds of rejections, as discussed below.
Claim Rejections - 35 USC § 112(a)
Written Description
Claims 1-3, 5-18 and 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim limitations in claim 1 that raise the written description issues comprise:
“… a sequence with at least 85 percent identity to SEQ ID NO:7 or 8 and having nuclease activity…” (line 3-4),
“… a sequence encoding a protein having at least 85 percent identity to any of SEQ ID NOs: 2, 4, 6, and 9…” (line 10-11),
The Applicant describes the amino acid sequence of wild type LbCas12a polypeptide consisting of SEQ ID NO: 46 (Spec, page 11, para 072). SEQ ID NOs: 2, 4, 6 and 9 encodes different codon optimized variants of LbCas12a polypeptide to be expressed in different organisms like Homo sapiens, rice and Arabidopsis (page 8, para 035-042). SEQ ID NO: 7 encodes the codon optimized cDNA polynucleotide while SEQ ID NO: 8 encodes codon optimized SEQ ID NO: 7 with 8 introns to be expressed in Arabidopsis and both encode the protein comprising SEQ ID NO: 9 (page 8, para 040-042).
Mutating up to 15% in the 3684 nucleotide long SEQ ID NO: 7 would allow mutating up to 552 nucleotides, which would mutate up to 184 amino acids in the polypeptide (SEQ ID NO: 9) it encodes. Mutating up to 15% in the 4622 nucleotide long SEQ ID NO: 8 would allow mutating up to 693 nucleotides (along the entirety of the polynucleotide sequence that comprises the coding regions, intron-exon junctions and the introns), which would allow mutating up to 639 amino acids in the same polypeptide (SEQ ID NO: 9) it encodes. Similarly, mutating up to 15% in 1227-1228 amino acid long SEQ ID NOs: 2, 4, 6 and 9 would allow mutating up to 184 amino acid residues along the entire length of the protein.
The Applicant does not describe any representative working examples of the broad genus comprising a sequence having less than 99.9% identity to SEQ ID NO: 2, 4, 6 and 9.
The Applicant also does not describe any structure function relationship of the protein sequences of SEQ ID NOs: 2, 4, 6 and 9 with the endonuclease function that the mutated protein needs to retain/achieve. The Applicant does not describe and it is not known which amino acid must not be mutated and/or which amino acid(s) would tolerate what type of mutation(s) while retaining/achieving the endonuclease function.
Current status of the art also does not describe any structure function relationship that would enable an ordinarily skilled artesian to mutate up to 15% of SEQ ID NOs: 2, 4, 6-8 and 9 anywhere in the entire length of the proteins while retaining/achieving the endonuclease function.
Considering the breadth of the claims, lack of representative species of the broad genus claimed, lack of structure function relationship of the broad genus claimed, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Applicant’s Arguments: The Applicant’s response dated 10/27/2025 is fully considered but not found persuasive. The Applicant argues that the specification discloses each of the sequences (SEQ ID NOs: 2, 4, 6-17) encompassed by the claims (response, p.10-11). The Applicant continues to argue that “the Application discloses exact polynucleotide and amino-acid sequences for multiple engineered Cas12a variants and their intron-containing embodiments, plus the wild-type LbCas12a sequence for reference to position numbering” (p. 12, last para last 3 lines) and provides functional evidence of nuclease activity and enhanced plant (genome) editing efficiencies with these engineered variants and guide architectures, including the generation and inheritance of edits. These disclosures are more than sufficient to show that Applicant possessed and enabled the full scope of the claims as amended” (p. 12, para 2-3).
The Examiner disagrees. SEQ ID NO: 7 described by the applicant encodes a LbCas12a protein with the D156R mutation while SEQ ID NO: 8 comprises the same nucleotide sequence but with an intron (bridging paragraph between spec, p. 8-9). The other sequences encode the same LbCas12a protein (with or without D156R mutation), e.g., SEQ ID NO: 2, 4, 6 and 9, also encodes the same LbCas12a protein codon optimized for expression in different plants like rice (SEQ ID NO: 2), human (SEQ ID NO: 4, and 6), Arabidopsis (SEQ ID NO: 9) (spec, p. 8-9).
The Applicant does not describe a representative example of sequences with less than 100% sequence identity to instant SEQ ID NO: 7, which is 3684 nucleotide long and encodes 639 amino acid residues (SEQ ID NO: 9). The same logic is valid for all the sequences described above. Only one codon or one amino acid at position 156 is described in terms of the functionality of the LbCas12a protein.
The Applicant also does not describe which amino acid(s) (other than D156) in the LbCas12a protein is/are crucial for its nuclease activity and/or DNA binding activity, which amino acid(s) (other than D156) can be mutated without changing the function of the protein. The instant description of the invention would not allow a skilled artisan to mutate up to 15% of the nucleotides encoding a Cas12a or 15% of the Cas12a polypeptide, and still retain its Cas nuclease and DNA binding activity. The sequences in the sequence listing are not representative of the broad genus encompassed by the claims.
Claim Rejections - 35 USC § 103
Claims 1-18 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Zhang et al. (US 2021/0348144 Al, published on 11 November 2021) and in evidence of Alexandrov et al. (US 10329575 B2) and Green et al. (Southern Blotting, 2021, Cold Spring Harb. Protoc., 7, PMID: 34210769).
Zhang et al. describes many recombinant DNA molecules cloned in a vector (page 3, para 0011-0012; page 91, para 0099, line 2-4). Zhang et al. teaches that majority of the mutations at position 156 (D156) in a LbCas12a nuclease are tolerated well (page 7, para 0025, line 1-3) and
the D156R mutation (as recited in claim 5) is a beneficial mutation for LbCas12a (page 91, para 0095, line 1-2) and it shows a (endonuclease) phenotype scores greater than wild type (page 91, para 0094, line 4-6). Zhang et al. describes a protein comprising 100% sequence identity (as recited in claims 1-3) to instant SEQ ID NO: 9 which is encoded by instant polynucleotide sequences of SEQ ID NO: 7 (cDNA sequence without any intron) and SEQ ID NO: 8 (cDNA sequence with 8 introns) (as recited in claim 4), as shown below.
RESULT 1
US-17-245-401-2030
Sequence 2030, US/17245401
Patent No. 11965185
GENERAL INFORMATION
APPLICANT: INTEGRATED DNA TECHNOLOGIES INC.
APPLICANT: ZHANG, Liyang
APPLICANT: VAKULSKAS, Christopher A
TITLE OF INVENTION: LACHNOSPIRACEAE SP. CAS12A MUTANTS
FILE REFERENCE: 013670-9067-US02
CURRENT APPLICATION NUMBER: US/17/245,401
CURRENT FILING DATE: 2021-04-30
PRIOR APPLICATION NUMBER: US 63/018,592
PRIOR FILING DATE: 2020-05-01
PRIOR APPLICATION NUMBER: US 63/090,912
PRIOR FILING DATE: 2020-10-13
NUMBER OF SEQ ID NOS: 5320
SEQ ID NO 2030
LENGTH: 1228
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 6395; Length 1228; Best Local Similarity 100.0%;
Matches 1227; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSKLEKFTNCYSLSKTLRFKAIPVGKTQENIDNKRLLVEDEKRAEDYKGVKKLLDRYYLS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSKLEKFTNCYSLSKTLRFKAIPVGKTQENIDNKRLLVEDEKRAEDYKGVKKLLDRYYLS 60
Qy 61 FINDVLHSIKLKNLNNYISLFRKKTRTEKENKELENLEINLRKEIAKAFKGNEGYKSLFK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FINDVLHSIKLKNLNNYISLFRKKTRTEKENKELENLEINLRKEIAKAFKGNEGYKSLFK 120
Qy 121 KDIIETILPEFLDDKDEIALVNSFNGFTTAFTGFFRNRENMFSEEAKSTSIAFRCINENL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KDIIETILPEFLDDKDEIALVNSFNGFTTAFTGFFRNRENMFSEEAKSTSIAFRCINENL 180
Qy 181 TRYISNMDIFEKVDAIFDKHEVQEIKEKILNSDYDVEDFFEGEFFNFVLTQEGIDVYNAI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TRYISNMDIFEKVDAIFDKHEVQEIKEKILNSDYDVEDFFEGEFFNFVLTQEGIDVYNAI 240
Qy 241 IGGFVTESGEKIKGLNEYINLYNQKTKQKLPKFKPLYKQVLSDRESLSFYGEGYTSDEEV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 IGGFVTESGEKIKGLNEYINLYNQKTKQKLPKFKPLYKQVLSDRESLSFYGEGYTSDEEV 300
Qy 301 LEVFRNTLNKNSEIFSSIKKLEKLFKNFDEYSSAGIFVKNGPAISTISKDIFGEWNVIRD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LEVFRNTLNKNSEIFSSIKKLEKLFKNFDEYSSAGIFVKNGPAISTISKDIFGEWNVIRD 360
Qy 361 KWNAEYDDIHLKKKAVVTEKYEDDRRKSFKKIGSFSLEQLQEYADADLSVVEKLKEIIIQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KWNAEYDDIHLKKKAVVTEKYEDDRRKSFKKIGSFSLEQLQEYADADLSVVEKLKEIIIQ 420
Qy 421 KVDEIYKVYGSSEKLFDADFVLEKSLKKNDAVVAIMKDLLDSVKSFENYIKAFFGEGKET 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 KVDEIYKVYGSSEKLFDADFVLEKSLKKNDAVVAIMKDLLDSVKSFENYIKAFFGEGKET 480
Qy 481 NRDESFYGDFVLAYDILLKVDHIYDAIRNYVTQKPYSKDKFKLYFQNPQFMGGWDKDKET 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 NRDESFYGDFVLAYDILLKVDHIYDAIRNYVTQKPYSKDKFKLYFQNPQFMGGWDKDKET 540
Qy 541 DYRATILRYGSKYYLAIMDKKYAKCLQKIDKDDVNGNYEKINYKLLPGPNKMLPKVFFSK 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 DYRATILRYGSKYYLAIMDKKYAKCLQKIDKDDVNGNYEKINYKLLPGPNKMLPKVFFSK 600
Qy 601 KWMAYYNPSEDIQKIYKNGTFKKGDMFNLNDCHKLIDFFKDSISRYPKWSNAYDFNFSET 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 KWMAYYNPSEDIQKIYKNGTFKKGDMFNLNDCHKLIDFFKDSISRYPKWSNAYDFNFSET 660
Qy 661 EKYKDIAGFYREVEEQGYKVSFESASKKEVDKLVEEGKLYMFQIYNKDFSDKSHGTPNLH 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 EKYKDIAGFYREVEEQGYKVSFESASKKEVDKLVEEGKLYMFQIYNKDFSDKSHGTPNLH 720
Qy 721 TMYFKLLFDENNHGQIRLSGGAELFMRRASLKKEELVVHPANSPIANKNPDNPKKTTTLS 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 TMYFKLLFDENNHGQIRLSGGAELFMRRASLKKEELVVHPANSPIANKNPDNPKKTTTLS 780
Qy 781 YDVYKDKRFSEDQYELHIPIAINKCPKNIFKINTEVRVLLKHDDNPYVIGIDRGERNLLY 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 YDVYKDKRFSEDQYELHIPIAINKCPKNIFKINTEVRVLLKHDDNPYVIGIDRGERNLLY 840
Qy 841 IVVVDGKGNIVEQYSLNEIINNFNGIRIKTDYHSLLDKKEKERFEARQNWTSIENIKELK 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 IVVVDGKGNIVEQYSLNEIINNFNGIRIKTDYHSLLDKKEKERFEARQNWTSIENIKELK 900
Qy 901 AGYISQVVHKICELVEKYDAVIALEDLNSGFKNSRVKVEKQVYQKFEKMLIDKLNYMVDK 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 AGYISQVVHKICELVEKYDAVIALEDLNSGFKNSRVKVEKQVYQKFEKMLIDKLNYMVDK 960
Qy 961 KSNPCATGGALKGYQITNKFESFKSMSTQNGFIFYIPAWLTSKIDPSTGFVNLLKTKYTS 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 KSNPCATGGALKGYQITNKFESFKSMSTQNGFIFYIPAWLTSKIDPSTGFVNLLKTKYTS 1020
Qy 1021 IADSKKFISSFDRIMYVPEEDLFEFALDYKNFSRTDADYIKKWKLYSYGNRIRIFRNPKK 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 IADSKKFISSFDRIMYVPEEDLFEFALDYKNFSRTDADYIKKWKLYSYGNRIRIFRNPKK 1080
Qy 1081 NNVFDWEEVCLTSAYKELFNKYGINYQQGDIRALLCEQSDKAFYSSFMALMSLMLQMRNS 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 NNVFDWEEVCLTSAYKELFNKYGINYQQGDIRALLCEQSDKAFYSSFMALMSLMLQMRNS 1140
Qy 1141 ITGRTDVDFLISPVKNSDGIFYDSRNYEAQENAILPKNADANGAYNIARKVLWAIGQFKK 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 ITGRTDVDFLISPVKNSDGIFYDSRNYEAQENAILPKNADANGAYNIARKVLWAIGQFKK 1200
Qy 1201 AEDEKLDKVKIAISNKEWLEYAQTSVK 1227
|||||||||||||||||||||||||||
Db 1201 AEDEKLDKVKIAISNKEWLEYAQTSVK 1227
The said sequence, as described by Zhang et al., comprises 99% sequence identity to instant SEQ ID NO: 46 (data not shown). Zhang et al teaches that the WT LbCas12a endonucleases are thought to be toxic which cause poor transformation efficiency and editing efficiency (page 91, para 0097, line 9-11). Zhang et al. describes expressing a guide RNA (gRNA) compatible with the Lbcas12a protein, as recited in claim 24 (page 7, para 0027, line 9-12).
However, Zhang et al. does not describe any intron sequence comprising any one of SEQ ID NOs: 10-17.
Hahn et al. describes introducing an intron in a transgene being cloned in bacteria to preventing cytotoxic effect of the cloned nucleic acid sequence(s) on bacterial cells used for cloning (column 13, line 36-38). It also describes an intron sequence having 100% sequence identity to instant SEQ ID NO: 13 (as recited in claims 1-3 and 6), as shown below.
RESULT 5
US-16-577-484-23
Sequence 23, US/16577484
Patent No. 11161886
GENERAL INFORMATION
APPLICANT: Nomad Bioscience GmbH
TITLE OF INVENTION: Bacteriocins for control of Salmonella enterica
FILE REFERENCE: 17317
CURRENT APPLICATION NUMBER: US/16/577,484
CURRENT FILING DATE: 2019-09-20
PRIOR APPLICATION NUMBER: EP 17 162 784.7
PRIOR FILING DATE: 2017-03-24
PRIOR APPLICATION NUMBER: PCT/EP2018/055479
PRIOR FILING DATE: 2018-03-06
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 23
LENGTH: 15014
TYPE: DNA
ORGANISM: Artificial Sequence
OTHER INFORMATION: nucleotide sequence of binary TMV-based vector used for salmocin
ScolE1a expression
Query Match 100.0%; Score 121; Length 15014; Best Local Similarity 100.0%;
Matches 121; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GTTAGTATCATATGAAGAAATACCTAGTTTCAGTTGATGAATGCTATTTTCTGACCTCAG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 9425 GTTAGTATCATATGAAGAAATACCTAGTTTCAGTTGATGAATGCTATTTTCTGACCTCAG 9484
Qy 61 TTGTTCTCTTTTGAGAATTATTTCTTTTCTAATTTGCCTGATTTTTCTATTAATTCATTA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 9485 TTGTTCTCTTTTGAGAATTATTTCTTTTCTAATTTGCCTGATTTTTCTATTAATTCATTA 9544
Qy 121 G 121
|
Db 9545 G 9545
Alexandrov et al. describes many introns including a couple of sequences (SEQ ID NOs: 15409 and 16442) having 100% sequence identity to instant SEQ ID NO: 15 (data not shown) (as recited in claims 1-3 and 6) to be used in plant expression systems. Alexandrov et al. describes transforming monocots (column 502, line 6) and dicots (column 502, line 58-59) (as recited in claims 9-10 and 17) using Agrobacterium cells (column 502, line 57-58) (as recited in claims 15-16).
Before the filing date of the invention, it would have been obvious to an ordinarily skilled artesian to express a recombinant DNA molecule encoding a Cas12a nuclease protein comprising 100% identical sequence to instant SEQ ID NO: 9 and comprising the modification of D156R substitution, with a realistic goal to increase genome editing efficiency of the LbCas12a endonuclease, as described by Zhang et al. Zhang et al. describe that the WT LbCas12a endonucleases are toxic to the host cells and causes poor transformation efficiency and editing, as discussed above. Thus, it also would have been more obvious to the artesian to add at least one intron sequence comprising SEQ ID NOs: 13 and/or 15 to the recombinant DNA molecule encoding the LbCas12a protein to avoid harmful effects of the cloned polynucleotide sequence on bacteria during cloning while increasing expression of the LbCas12a gene in the plant cells, as taught by Hahn et al. and Alexandrov et al.
Before the filing date, an ordinarily skilled artesian would have been motivated to express a recombinant DNA molecule encoding a protein comprising a 100% identical sequence to instant SEQ ID NO: 9 along with the D156R substitution, with a realistic goal to increase genome editing efficiency of the wild type LbCas12a endonuclease. The artesian would also be motivated to add at least one intron sequence comprising SEQ ID NOs: 13 and/or 15 to the recombinant DNA molecule encoding the LbCas12a protein to avoid harmful effects of the cloned polynucleotide sequence on bacterial cells during cloning while increasing expression of the LbCas12a gene in the host plant.
Regarding claims 2-3, Zhang et al. describes a recombinant DNA molecule comprising a polynucleotide sequence comprising more than 90% (as recited in claim 2) and also more than 95% sequence identity (as recited in claim 3) to SEQ ID NO: 9, which is encoded by SEQ ID NOs: 7-8, as discussed above.
Regarding claims 7-18 and 23-24, Transforming a plant cell from a monocotyledonous plant like rice, wheat, and corn/maize or a dicotyledonous plant including cotton, citrus, poplar using agrobacterium mediated transformation and using a recombinant DNA molecule is a routine and standard process in the art. Introducing a genomic modification in a plant cell by using CRISPR-Cas mediated genome editing that uses a guide RNA compatible with a suitable endonuclease (e.g., Cas12a), regenerating the genome-edited or transgenic plants, growing the plants from the seeds, and harvesting seeds (as recited in claim 23-24) are also a routine and standard process in the art, It’s well acknowledged in the art that cells in a transgenic plant would have the same recombinant DNA molecule which the plant was transformed with.
Regarding claim 25, the method of detecting the presence of a recombinant DNA molecule, with partly or fully known sequence, using a DNA probe that hybridizes under specific (“stringent”) hybridization conditions with genomic DNA from a plant is well-known and widely used method. The method is commonly referred to as “Southern blot hybridization (SBH)” (Green et al., Southern Blotting, 2021, Cold Spring Harb. Protoc., 7, PMID: 34210769).
The method comprises contacting plant genomic DNA sample with a DNA probe that hybridizes under specific (stringent) hybridization conditions with genomic DNA from a plant comprising the recombinant nucleic DNA. It would have been obvious to an ordinarily skilled artesian and s/he would have been motivated to use a probe homologous or complementary to SEQ ID NO: 3 to detect the presence of the recombinant DNA molecule in the transgenic plant genome, as described above.
Response to Applicant’s Argument: The Applicant’s response dated 10/27/2025 is fully considered but not found persuasive. Regarding 35 U.S.C.103 rejection, the Applicant argues, “This rationale is insufficient for at least three reasons.” (response, page 16, last para, last 2 lines).
The choice of these particular introns, their compatibility with the codon-optimized CDS, and the cooperative effect on editing efficiency in plant systems are not taught or suggested in the cited art (response, page 17, first para, line 4-6).
Without these teachings of the instant specification, one of ordinary skill would face significant uncertainty regarding whether, which, and how many introns could be used without disrupting translation, nuclear localization signals, or the nuclease's function. Applicants also allege unexpected results (response, page 17, para 2, line 5-8, p. 18-20).
The references do not collectively suggest combining D156R with introns in Cas12a to solve the plant recalcitrance problem (response, page 17, para 3, line 1-2).
The Examiner disagrees because-.
Codon optimization for plant specific expression of a heterologous protein is a well-known and a standard process in the art. Zhang et al also describe codon-optimized variants encoding LbCas12 mutants (page 21, para 0070, line 6-13).
There are even examples of specific codon optimization for specific temperature-tolerant LbCas12a gene comprising the specific D156R substitution mutation for plant expression (Schindele et al., Engineering CRISPR/LbCas12a for highly efficient, temperature-tolerant plant gene editing, 2020, Plant Biotechnology Journal, 18:1118–1120; page 1118, right column, para 1, line 2-9).
Using introns to avoid cytotoxicity and/or enhance transgene expression is also a routine and standard process in the art as described by Alexandrov et al., as discussed above. Intron mediated enhancement (IME) is a well-known and widely used method to enhance transgene expression in plants (Laxa, M, Intron-Mediated Enhancement: A Tool for Heterologous Gene Expression in Plants? Front. Plant Sci. 7:1977; title and abstract). Structures within an intron and around the intron-exon boundaries are also well characterized to clone such introns for specific use. The nuclease's function of a Cas12a protein would not depend on intron sequence, in the absence of evidence to the contrary.
Zhong et al. (Intron-Based Single Transcript Unit CRISPR Systems for Plant Genome Editing, 2020, Rice, 13:8) describes using introns in the Cas9 and Cas12a coding sequences to be expressed in three different plants (abstract). It is the opinion of the Applicant that expressing a LbCas12a gene comprising the D156R and intron(s) in Cas12a gene would make the plant become recalcitrant. The Applicant does not provide any evidence. Applicant’s opinion cannot take the place of evidence (MPEP 716.01(c)(II), 2145(I)).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
Prosecution Insights